Hélio José Castello

Three vs Twelve Months of Dual Antiplatelet Therapy After Zotarolimus-Eluting Stents The OPTIMIZE Randomized Trial

IMPORTANCE The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. OBJECTIVE To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTS The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents. INTERVENTIONS After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURES The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). CONCLUSIONS AND RELEVANCE In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01113372.

Comparison of direct stenting versus stenting with predilation for the treatment of selected coronary narrowings.

Direct stenting may reduce costs, procedure times, and injury to the vessel wall, positively influencing acute and late results. This study was designed to demonstrate 6-month clinical outcome equivalence between direct and standard stenting techniques. Four hundred eleven patients (425 lesions) were randomized in 7 sites to undergo direct (210 patients, 216 lesions) or conventional (201 patients, 209 lesions) stent implantation. Lesions with severe calcification were excluded. Angiographic success rate was 100% in the direct stent group (2.8% requiring balloon predilation) and 98.6% in the predilation group (p = 0.12). Direct stenting was associated with decreased use of balloons (0.15 vs 1.09 balloons/lesion treated) and with a trend toward a reduction of procedure time (22.7 +/- 15.0 vs 25.6 +/- 18.2 minutes; p = 0.073). Fluoroscopy time and contrast volume were not different between groups. At 6-month follow-up, the incidences of death (direct [1.4%] vs predilation [2.5%]), myocardial infarction (5.3% vs 5.0%), and target vessel revascularization (8.2% vs 10.5%) were similar in both groups. Major adverse cardiac event-free survival rate was 87.5% for those who underwent the direct stent technique and 85.5% for patients who underwent predilation (p = 0.0002 for equivalence). In conclusion, direct stenting is at least equivalent to the standard technique in terms of 6-month clinical outcomes when performed on selected coronary lesions without significant calcification. This strategy is associated with decreased use of balloons, but, in general, does not significantly reduce procedure times.

Lung and myocardial thallium-201 kinetics in resting patients with congestive heart failure: Correlation with pulmonary capillary wedge pressure

Increased lung thallium-201 activity occurs with exercise in patients with severe coronary artery disease as a result of increased pulmonary capillary wedge pressure. No study has shown resting lung kinetics in chronic congestive heart failure. To better understand the relationship between lung and myocardial thallium uptake and pulmonary capillary wedge pressure, this study was performed. Resting lung and myocardial thallium uptake, expressed as a ratio, were compared with simultaneous pulmonary capillary wedge pressure in 16 patients with congestive heart failure and cardiomyopathy, all New York Heart Association class IV. There were no variations in pulmonary capillary wedge pressure throughout the study protocol. There was a significant reduction in the lung/myocardium thallium ratio from 10 to 60 minutes (0.83 +/- 0.30 to 0.59 +/- 0.17; p less than 0.001). At 60 minutes after thallium injection there was a linear correlation between the lung/myocardium ratio and capillary wedge pressure with an r value of 0.62 (p less than 0.01). Thus thallium-201 washout is rapid despite persistence of pulmonary capillary wedge pressure elevation, indicating that clearance does not imply resolution of congestive heart failure. In addition, a significant but imprecise correlation was found between capillary pressure and the lung/myocardium ratio. Rapid changes in lung activity during the early postinjection period may limit the clinical use of the lung/myocardium ratio.

Optimized duration of clopidogrel therapy following treatment with the Endeavor zotarolimus-eluting stent in real-world clinical practice (OPTIMIZE) trial: rationale and design of a large-scale, randomized, multicenter study.

BACKGROUND Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation include prolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel ≥12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific evidence available to date. Also, several other shortcomings have been identified with prolonged DAPT, including bleeding complications, compliance, and cost. The second-generation Endeavor zotarolimus-eluting stent (E-ZES) has demonstrated efficacy and safety, despite short duration DAPT (3 months) in the majority of studies. Still, the safety and clinical impact of short-term DAPT with E-ZES in the real world is yet to be determined. METHODS The OPTIMIZE trial is a large, prospective, multicenter, randomized (1:1) non-inferiority clinical evaluation of short-term (3 months) vs long-term (12-months) DAPT in patients undergoing E-ZES implantation in daily clinical practice. Overall, 3,120 patients were enrolled at 33 clinical sites in Brazil. The primary composite endpoint is death (any cause), myocardial infarction, cerebral vascular accident, and major bleeding at 12-month clinical follow-up post-index procedure. CONCLUSIONS The OPTIMIZE clinical trial will determine the clinical implications of DAPT duration with the second generation E-ZES in real-world patients undergoing percutaneous coronary intervention.

Tratamento percutâneo de pseudoaneurismas por injeção de trombina guiada por ultrassom

ABSTRACT Percutaneous Treatment of Pseudoaneurysms byUltrasound-guided Thrombin Injection Background: Iatrogenic pseudoaneurysm is observed in0.5% to 2% of diagnostic percutaneous procedures and inup to 7% to 8% of therapeutic percutaneous procedures.Pseudoaneurysm occlusion by ultrasound-guided thrombininjection directly in the aneurysm sac is a minimally in-vasive, quick and safe procedure with a high success rate.The aim of our study is to report our initial experience intreatment of iatrogenic pseudoaneurysms by ultrasound-gui-ded thrombin injection. Method: Between September 2006and February 2010, 1,811 percutaneous coronary inter-ventions were carried out with an occurrence of 15 pseu-doaneurysms (0.8%), of which 13 were consecutively treatedby ultrasound-guided thrombin injection. Clinical charac-teristics, type of percutaneous procedure, adjuvant the-rapy, size and morphology of pseudoaneurysms, thrombindose, success and complication rate were prospectively docu-mented and later retrospectively analyzed.

Stents farmacológicos liberadores de Everolimus XienceTM V no tratamento de pacientes com lesões coronárias complexas na prática diária: resultados iniciais do registro brasileiro BRAVO

BACKGROUND: The XienceTM V everolimus-eluting stent (Abbott Vascular, Santa Clara, USA), a second-generation drug-eluting stent (DES) has demonstrated sustained efficacy and safety in the treatment of selected patients with coronary lesions. However, the impact of the XienceTM V stent in populations from daily clinical practice with complex lesions has not yet been fully determined. METHODS: The BRAVO Registry was a prospective, non-randomized, multicenter study that evaluated the late clinical outcomes of minimally selected patients treated with XienceTM V DES in the Brazilian daily clinical practice. Overall, 535 patients were included in 25 clinical sites between September/2008 and September/2010. Major adverse cardiac events (MACE) were defined as cardiac death, acute myocardial infarction (AMI) and target vessel revascularization (TVR). RESULTS: Mean age was 62.7 + 11.1 years, 40% had diabetes, 24.9% had a previous AMI and 41.9% presented with acute coronary syndrome. About two thirds of the patients had type B2/C lesions and 46.1% treated the left anterior descending artery. Multiple stenting procedures were performed in 13.8% of cases and angiographic success was > 99%. During hospitalization, periprocedural AMI rate was 1.9%. At the 6-month follow-up, cumulative rates of cardiac death, AMI and TVR were 1.1%, 2.2% and 1.3%, respectively (MACE rate: 4.3%). There were 4 cases of stent thrombosis (defined according to the Academic Research Consortium ARC) reported within 6 months, representing an event rate of 0.75% (0.4% definite/probable). CONCLUSIONS: In this Registry including complex patients and lesions treated at multiple sites in Brazil, the XienceTM V second generation DES demonstrated excellent immediate results and sustained clinical efficacy and safety at mid-term follow-up (6 months). Long-term results are expected.

Resultados da intervenção coronária percutânea primária em pacientes do Sistema Único de Saúde e da saúde suplementar

BACKGROUND: Primary percutaneous coronary intervention (PCI) is the most effective reperfusion technique in acute myocardial infarction (AMI) and its success rate depends on many factors. This study aimed to assess the profile and to compare in-hospital outcomes of primary PCI among patients from the Public Healthcare System (PuHS) versus those from the Private Healthcare System (PrHS). METHODS: From 2006 to 2010, 493 patients were submitted to primary PCI, of which 220 were treated by the PuHS and 273 by the PrHS. Procedure technique and materials were left to the operators discretion. RESULTS: The PuHS group had a larger number of Killip > 1 patients. Multivessel coronary disease, pre-procedure coronary flow TIMI 0/1 and the presence of collaterals for the treated vessel did not differ between groups. The PrHS group used more thromboaspiration catheters (10% vs. 20.8%; P < 0.01) and glycoprotein IIb/IIIa inhibitors (24.1% vs. 36.6%; P < 0.01). There was no difference for door-to-balloon times (62.3 minutes vs. 64.2 minutes; P = 0.91). For patients referred from other hospitals, however, transportation times were higher for PuHS patients (400.8 minutes vs. 262.4 minutes; P < 0.01). PCI success rates and the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) did not differ between groups (6.3% vs. 6.2%; P = 0.1). Age, Killip III/IV and transportation time were the variables that best explained the occurrence of MACCE. CONCLUSIONS: Differences in the clinical, angiographic and procedure profile of patients undergoing primary PCI treated by the PuHS and the PrHS did not have an impact on MACCE. Transportation times, however, high in both groups and higher in the PuHS group, proved to be an independent predictor of adverse events.

Impacto do tabagismo nos resultados da intervenção coronária percutânea

BACKGROUND: Smoking is an important atherothrombotic risk factor, observed in one third of patients undergoing per-cutaneous coronary intervention (PCI) at our service. The objective of the present study was to analyze the clinical angiographic profile and the results of the procedure in this population. METHOD: From January 2002 to October 2009, 5,466 PCI procedures were carried out, of which 1,745 in smokers and 3,721 in non-smokers. All data were prospectively obtained and patients were followed-up during hospitalization. RESULTS: In the group of smokers, there was prevalence of males (75.2% vs. 62.1%; P < 0.001), younger patients (56.4 years vs. 64.5 years; P < 0.001), acute myocardial infarction (AMI) with ST-segment elevation (37.5% vs. 19.5%; P < 0.001), single-vessel disease (56.5% vs. 47%; P < 0.001), long lesions (14.7% vs. 12%; P < 0.001), bifurcations (5.6% vs. 3.9%; P = 0.002), thrombotic lesions (15.4% vs. 9%; P < 0.001), total occlusions (18.2% vs. 11.2%; P < 0.001) and greater use of IIb/IIIa inhibitors (2.5% vs. 1.6%; P = 0.04). Clinical success (96.5% vs. 96.1%; P = 0.5) as well as the need of emergency surgical revascularization (0.06% vs. 0.05%; P = 0.22), AMI (0.74% vs. 1.02%; P = 0.32) or death (0.63% vs. 0.73%; P = 0.69) were similar in both groups. Smokers, however, showed a trend towards a greater number of strokes during hospitalization (0.11% vs. 0.05%; P = 0.07). CONCLUSION: Smokers undergoing coronary angioplasty are eight years younger than non-smokers, present AMI with ST-segment elevation more frequently and have greater angiographic complexity. The use of modern technological resources allowed comparable in-hospital results, with the exception of stroke, whose incidence tends to be twice as high in smokers.

Intervenção Coronária Percutânea em Pacientes Jovens

Background: Cardiovascular disease has shown increasing occurrence rates among young people and data of percutaneous coronary intervention (PCI) in this group are scarce. Our objective was to perform a retrospective evaluation of the profile and in-hospital clinical outcomes of young patients in this PCI registry. Methods: From 2006 to 2012, 6,288 patients were consecutively submitted to PCI, of whom 151 were 0.99), myocardial infarction (3.3% vs. 2.3%; p = 0.41) or emergency revascularization (0.6% vs. 0.03%; p = 0.56) were similar between groups. In the multivariate analysis, age and presence of functional class Killip III and IV were the variables that best explained the occurrence of MACCE. Conclusions: Patients with age < 40 years represented a small fraction of the cases in this series and had a clinical and angiographic profile different from the older patients, suggesting the need to establish primary prevention measures earlier in individuals with the observed profile.

Stem-cell therapy in ST-segment elevation myocardial infarction with reduced ejection fraction: A multicenter, double-blind randomized trial

Left ventricular ejection fraction (LVEF) is a major determinant of long‐term prognosis after ST‐segment elevation myocardial infarction (STEMI). STEMI patients with reduced LVEF have a poor prognosis, despite successful reperfusion and the use of renin‐angiotensin‐aldosterone inhibitors.